Cascade Abrazo aPTT Test Card recall
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Why was Cascade Abrazo aPTT Test Card recalled?
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number 2-17-5722, Exp. 2018-09-30
- Product
- Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Recalling firm
- Helena Laboratories, Corp.
- Quantity
- 21 kits
- Distribution
- Distribution was made to Germany and Australia. There was no U.S. distribution.
- Recall date
- October 9, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)